510(k) K101329

SYNERGY CT PICC by Health Line International Corporation — Product Code LJS

K101329 is an FDA 510(k) premarket notification submitted by Health Line International Corporation for the device "SYNERGY CT PICC". The FDA issued a decision of Substantially Equivalent on August 19, 2010. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Health Line International Corporation has at least 10 other 510(k) clearances on record.